The TGA has urged clinicians to think twice about using the contrast agent gadolinium when ordering an MRI in light of new evidence that it can accumulate in the brain.
Product information for gadolinium-based contrast agents have previously stated that the contrast agent ‘does not cross the intact blood brain barrier’ but there is now increasing evidence that this may occur, the TGA said in an advisory this week.
“While no harmful effects of gadolinium retention in the brain have been identified at this time, the TGA is working with sponsors to update the PI documents and is recommending judicious use of gadolinium-based contrast agents, particularly linear agents,” the safety advisory notes.
In a statement the Royal Australian and New Zealand College of Radiologists advise that particular care should be taken with the use of gadolinium-based contrast agents in people with renal impairment, paediatric and obstetric patients.
Last month the European Medicines Agency recommended healthcare professionals use gadolinium contrast agents only when essential diagnostic information cannot be obtained with unenhanced scans.
The FDA has taken a different approach, noting that while it would not restrict the use of gadolinium contrast agents it would continue to monitor their safety.